Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After ESD

NCT ID: NCT06092281

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2029-12-31

Brief Summary

Endoscopic submucosal dissection (ESD) is now considered the standard treatment for early gastrointestinal neoplasms. However, there is still a possibility of developing local recurrence or metachronous neoplasia after ESD. Regular endoscopic surveillance after ESD can identify and remove local recurrences and metachronous lesions early, improving patient prognosis. However, the patient compliance with post-ESD endoscopic surveillance is currently unclear, and many patients fail to adhere to the scheduled follow-up. A prospective, randomized controlled, superiority trial was designed to evaluate whether completing a questionnaire and receiving feedback on compliance-related education can improve patient compliance with post-ESD endoscopic surveillance, in comparison to those who did not complete the compliance-related education questionnaire. Additionally, the investigators intend to investigate the factors that influence patient compliance.

This study will consist of two parts.

Part 1 will assess whether the completion of questionnaire and feedback on compliance-related education can improve short-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing short-term patient compliance.

Part 2 will assess whether the completion of questionnaire and feedback on compliance-related education can improve long-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing patient compliance.

Detailed Description

This is a prospective, randomized controlled, superiority trial. The study population consists of patients after ESD for mucosal lesions at Xijing Hospital. In the control arm, patients after ESD are informed on follow-up instructions by doctors about the follow-up requirements before discharge, and complete a questionnaire without compliance-related education. In the questionnaire arm, in addition to receiving the same follow-up instructions as the control arm, patients need to complete a questionnaire on compliance-related education before discharge. Based on the responses, nurses provide feedback and guidance. Patients and doctors will be blind to the group of patients during the trial process. Our objective is to evaluate whether completing a questionnaire and receiving feedback on compliance-related education can improve patient compliance with post-ESD endoscopic surveillance, in comparison to those who did not complete the compliance-related education questionnaire. Additionally, the investigators intend to investigate the factors that influence patient compliance.

Part 1 will assess whether the completion of questionnaire and feedback on compliance-related education can improve short-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing short-term patient compliance. Part 1 will be expected to include 220 post-ESD patients randomized 1:1 into the questionnaire arm and control arm. Sample size calculation is based on short-term compliance data from a pilot trial, with a 20% difference between the two groups. Under the conditions of an α error of 5% (in a one-sided test) and power of 80%, assuming a superiority margin of 5%, a sample size of 220 cases is required.

Part 2 will assess whether the completion of questionnaire and feedback on compliance-related education can improve long-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing patient compliance. Part 2 will be expected to include 500 post-ESD patients randomized 1:1 into the questionnaire arm and control arm. Under the conditions of an α error of 5% (in a one-sided test) and power of 80%, assuming a 20% difference between the two groups in long-term compliance outcome, a superiority margin of 10%, and rounding up, a sample size of 500 cases is required.

Conditions

Patient Compliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control Arm

Patients after ESD are informed on follow-up instructions by doctors about the follow-up requirements before discharge, and complete a questionnaire without compliance-related education.

Group Type: EXPERIMENTAL

Questionnaire without compliance-related education

Intervention Type: BEHAVIORAL

Patients after ESD need to complete a questionnaire without compliance-related education before discharge. The questionnaire includes only general information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.)

Questionnaire Arm

In addition to receiving the same follow-up instructions as the control group, patients need to complete a questionnaire on compliance-related education before discharge. Based on the responses, nurses provide feedback and guidance.

Group Type: EXPERIMENTAL

Questionnaire

Intervention Type: BEHAVIORAL

Patients after ESD need to complete a questionnaire on compliance-related education before discharge. The questionnaire includes the following information:

1. General information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.)

2. Awareness of follow-up examinations (e.g., knowledge about the timing of the first follow-up, the process of follow-up examinations, related educational issues about follow-up, etc.)

3. Awareness of the disease (self-perceived tumor is benign or malignant, whether lifestyle changes are required, etc.)

Interventions

Questionnaire

Patients after ESD need to complete a questionnaire on compliance-related education before discharge. The questionnaire includes the following information:

1. General information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.)

2. Awareness of follow-up examinations (e.g., knowledge about the timing of the first follow-up, the process of follow-up examinations, related educational issues about follow-up, etc.)

3. Awareness of the disease (self-perceived tumor is benign or malignant, whether lifestyle changes are required, etc.)

Intervention Type: BEHAVIORAL

Questionnaire without compliance-related education

Patients after ESD need to complete a questionnaire without compliance-related education before discharge. The questionnaire includes only general information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥18 years) after ESD for mucosal lesions.

Exclusion Criteria

• Patients after ESD for submucosal tumors, e.g. stromal tumors, neuroendocrine tumors;
• Additional radical surgery after ESD procedure;
• Past history of ESD procedure or local recurrence;
• Severe comorbidities with a life expectancy of <6 months as judged by the investigator;
• Unable to cooperate with information collection due to mental disorders, severe neurosis, or dysgnosia;
• Unable to understand or unwilling to sign a written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Zhiguo Liu

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiguo Liu

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive DIsease

Locations

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiguo Liu

Role: CONTACT

liuzhiguo@fmmu.edu.cn

86-29-84771535

Facility Contacts

Zhiguo Liu

Role: primary

liuzhiguo@fmmu.edu.cn

86-29-84771535

References

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Reference Type: BACKGROUND

PMID: 33107115 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 32072683 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 35523224 (View on PubMed)

Other Identifiers

KY20232292-F-1

Identifier Type: -

Identifier Source: org_study_id